This contains two active ingredients: Ethinylestradiol and Drospirenone. Ethinylestradiol is a synthetic version of estrogen, and Drospirenone is a synthetic form of progesterone. The hormonal components of this preparation inhibit ovulation by suppressing gonadotropin release. Secondary mechanisms that may contribute to the effectiveness of this tablet as a contraceptive include changes in the cervical mucus (which increase the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).

Drospirenone has antimineralocorticoid activity, counteracting estrogen-related sodium retention. In combination with Ethinylestradiol, Drospirenone displays a favorable lipid profile with an increase in high-density lipoprotein (HDL). Drospirenone exerts antiandrogenic activity and does not counteract the Ethinylestradiol-related sex hormone-binding globulin increase, which is useful for binding and inactivating the endogenous androgens.

Dosage

To achieve maximum contraceptive effectiveness, tablets must be taken in the order directed on the package every day at about the same time. Tablet-taking should be started with the first pink tablet of the upper row and continued daily for 24 consecutive days. After completing the pink tablets, white tablets should be taken from the 25th day to the 28th day. Withdrawal bleeding usually starts on days 2-3 after starting the white tablets. Do not stop taking white tablets, even if menstruation has already started. Each subsequent new pack should be started on the day after the last white tablet of the previous pack.

No preceding hormonal contraceptive use in the past month: Tablet taking must start on day 1 of the woman’s menstrual cycle. The woman should be instructed to take the first light pink active tablet from the upper row according to the direction, and no additional contraception methods are required. Starting on days 2-5 is allowed, but during the first cycle, a barrier method is recommended for the first 7 days of tablet-taking.

Changing from another combined hormonal pill or vaginal ring or transdermal patch: In case of a combined hormonal pill, the woman should start with the first light pink tablet of the upper row on the day after the last active tablet of her previous COC. In case of a vaginal ring or transdermal patch, the woman should start using this tablet preferably on the day of removal.

Changing from a progestogen-only-method (minipill, injection, implant) or from a progestogen-releasing intrauterine system (IUS): The woman may switch any day from the minipill (or from an implant or the IUS on the day of its removal, or from an injectable when the next injection would be due), but should in all of these cases be advised to additionally use a barrier method (e.g., condom) for the first 7 days of tablet-taking.

Following first-trimester abortion: The woman may start immediately, and in this case, no additional contraceptive method is needed.

Following delivery or second-trimester abortion: Women are advised to start at day 21 to 28 after delivery or second-trimester abortion. If starting later, a barrier method (like a condom) should be used for the first 7 days of tablet-taking.

Consult your doctor before taking this medication.

Administration

Management of Missed Tablets:

Missed white pills from the last row of the blister are placebo tablets and can be disregarded. If you forget to take a light pink tablet, take the missed tablet as soon as you remember. This may mean taking two tablets the next day. Additionally, you should use another contraception method (like a condom) for the next 7 days. If you forget to take the tablets for two consecutive days, you may no longer be protected against pregnancy. Discontinue the tablet and use another temporary method (condom/foam tablet) until your next menstruation. Discard the unfinished pack of tablets and start taking tablets from the light pink tablet of the new pack from the first day of your next menstruation.

If you have missed a period after taking the tablet:

If you have taken all of your pills at the right time and have not vomited or used other medicines, pregnancy is very unlikely. Continue taking the tablet as usual. If you miss your period twice in a row, you may be pregnant. Tell your doctor immediately. Do not start the next pack until your doctor confirms you’re not pregnant.

How to Delay a Period:

To delay your period, continue with a new pack of this tablet just after finishing the light pink active tablet of the present pack (i.e., no need to take the white placebo tablet). This extension can be carried on for as long as desired until the end of the light pink tablets in the second pack. When you wish for your period to begin, stop taking the tablets. Some breakthrough bleeding or spotting may occur while using the second pack. Start your next pack after the usual 4-day white inactive tablet interval.

Advice in case of Vomiting:

If vomiting occurs within 3-4 hours after taking the light pink tablet, absorption may not be complete. In such cases, follow the management of missed tablets. Take the extra active light pink tablet from a backup pack.

Consult your doctor before taking this medication.

Interaction

Interactions between Ethinylestradiol and other drugs may lead to decreased or increased Ethinylestradiol concentrations, respectively. Decreased Ethinylestradiol serum concentrations may cause increased breakthrough bleeding and menstrual irregularities, and may reduce contraceptive efficacy. Substances that may decrease Ethinylestradiol concentrations include Rifampicin, Phenytoin, Primidone, Rifabutin, Dexamethasone, Griseofulvin, Topiramate, some protease inhibitors, Modafinil, Ritonavir, and Barbiturates. Certain antibiotics (e.g., ampicillin, penicillins, and tetracyclines) may reduce the efficacy of oral contraceptives. When using this tablet with drugs that decrease Ethinylestradiol serum concentrations, a non-hormonal backup method of contraception is recommended in addition to regular tablet intake.

Contraindications

This tablet should not be used if:

• You are pregnant or suspect pregnancy

• You have heart disease or clotting disorders

• You suffer from liver disease or jaundice

• You suffer from high blood pressure, migraine, breast lumps, diabetes with vascular involvement, unexplained bleeding

• You have a history of venous or arterial thromboembolic events

• You have a history of migraine with neurological symptoms

• You have pancreatitis or a history of it with severe hypertriglyceridemia

• You have severe renal insufficiency or acute renal failure

• You have liver tumors (benign or malignant)

• You have undiagnosed vaginal bleeding

• You are hypersensitive to any of the components of this preparation

Side Effects

Side effects may occur in some women, such as dizziness, headache, breast pain, nausea, or unscheduled uterine bleeding. If you experience any inconvenience such as migraine, changes in eyesight or speech, unusual pain or swelling in your legs, sharp chest pains, or shortness of breath, rash, yellow skin, or a rise in blood pressure, seek immediate medical advice.

Pregnancy & Lactation

• Use during pregnancy: This tablet is contraindicated during pregnancy. Pregnancy must be excluded before starting this tablet. If pregnancy occurs during use, discontinue immediately.

• Use during lactation: Combined pills may reduce the quantity and change the composition of breast milk. The use of estrogen-containing combined pills is not recommended until the nursing mother has completely weaned her child. Small amounts of contraceptive steroids and/or their metabolites may be excreted in breast milk.

Precautions & Warnings

If you have any circulatory disorder (e.g., myocardial infarction, deep venous thrombosis, pulmonary embolism, cerebrovascular injury) or other risk factors (e.g., smoking, obesity, hypertension, dyslipidemia, migraine), the benefits and risks of using this oral contraceptive should be discussed with your physician before starting.

Use in Special Populations

• Pediatric Use: Indicated only after menarche.

• Use in the Elderly: Not indicated after menopause.

Overdose Effects

Overdose symptoms may include nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness/fatigue, and withdrawal bleeding. There is no specific antidote, and treatment is directed to the symptoms.

Therapeutic Class

Oral contraceptive preparations.

Storage Conditions

Store below 30°C. Keep away from light and out of reach of children.

Consult your doctor before using this medication.